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National Heart, Lung, and Blood Institute, NIH
U.S. Public Health Service, DHHS SPECIAL INSTRUCTIONS FOR PREPARATION OF
SPECIALIZED CENTERS FOR CELL-BASED THERAPY Specialized Centers for Cell-Based Therapy (SCCT) May 2004 TABLE OF CONTENTS A. INTRODUCTION B. GENERAL INFORMATION C. SPECIFIC INSTRUCTIONS FOR SPECIALIZED CENTERS OF CLINICALLY ORIENTED RESEARCH (SCCT) APPLICATIONS
ILLUSTRATIONS Table 1 - Detailed Budget for Initial Budget Period Table 2 - Relation of Core Units to Research Projects A. Introduction These instructions provide information needed for preparation of an application for a Specialized Center for Cell-based Therapy (SCCT) described in the announcement “Specialized Centers for Cell-Based Therapy (SCCT) for Heart, Lung, and Blood Diseases and Data and Coordinating Center (DCC),” RFA HL-04-017 at http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-04-017.html. Applicants preparing submissions for the Data & Coordinating Center for RFA HL-04-017 should not use these instructions. Instead these applicants should use the general instructions for preparation of NIH grant applications that are contained in the standard NIH grant application kit (PHS Form 398).The most recent version is available at http://grants2.nih.gov/grants/funding/phs398/phs398.html. B. General Information General instructions for preparation of NIH grant applications are contained in the standard NIH grant application kit (PHS Form 398) available on the internet at http://grants2.nih.gov/grants/funding/phs398/phs398.html and usually available at an applicant institution's business office. Even though the application kit is intended primarily for the regular research-project grant, some of the general instructions and forms in it also apply to SCCT grant applications. However, SCCT grants have special characteristics. Accordingly, the specific instructions in this document were prepared for use with the grant application kit. The application should not be prepared as a modular grant as described in the PHS 398. If questions arise, it is recommended that applicants contact staff at the National Heart, Lung, and Blood Institute. To the extent possible, the Institute is prepared to discuss plans for developing an application. Inquiries about preparation of SCCT applications should be addressed to: John Thomas, Ph.D. 1. FACE PAGE (Form Page 1*) (*Refers to appropriate form in NIH grant application kit PHS 398)
2. DESCRIPTION, PERFORMANCE SITES, AND KEY PERSONNEL (Form Page 2)
3. RESEARCH GRANT TABLE OF CONTENTS
4. DETAILED BUDGET FOR INITIAL BUDGET PERIOD (Form Page 4) For a SCCT, a detailed budget will be required for EACH PROJECT AND EACH CORE UNIT in their respective sections of the application. (See below under Research Plan in this document).
5. BUDGET FOR ENTIRE PROPOSED PERIOD (Form Page 5)
6. BIOGRAPHICAL SKETCH (Biographical Sketch Format Page)
7. RESOURCES See section 8.b. below, Institutional Environment and Resources. 8. RESEARCH PLAN Each project should follow the format for the PHS Form 398 and provide supplementary information when necessary for each section as indicated below.
Page limitations specified for individual (R01) grant applications in PHS Form 398 apply to each project and core unit section
The following sections should precede the individual projects.
a. Program Introduction and Statement of Objectives A SCCT should be viewed as a group of interrelated research projects, each of which is not only individually meritorious scientifically but is also complementary to the other projects in the research program and contributes to the integrating theme. The theme of the proposed SCCT should be established in the first few sentences of the general introduction. Describe the rationale for the proposed total research program. Explain the strategy for achieving the objectives of the overall program and how each research project and core unit relates to that strategy. The general introduction of the overall program description is the appropriate place to indicate any prior collaborative arrangements between investigators in the group, to emphasize the events that have led to the current application, to anticipated unique advantages that would be gained by the research within the proposed SCCT, to describe how the projects are synergistic and mutually reinforcing, and to explain how the projects collectively would enhance the stated objective of the proposed research. b. Institutional Environment and Resources Briefly describe the features of the institutional environment that are relevant to the effective implementation of the overall program. As appropriate, describe available resources such as clinical and laboratory facilities, participating and affiliated units, patient populations, geographic distribution of space and personnel, and consultative resources. The information requested here supplants the "Resources" page in the PHS Form 398 grant application, which is NOT to be used in describing the overall SCCT program. c. Organizational and Administrative Structure of a SCCT Describe in detail, and by diagram, if appropriate, the chain of responsibility for decision-making and administration, beginning at the level of SCCT Director and including investigators responsible for the direction of the research projects and core units. The Director of the overall SCCT is called the principal investigator; the leaders of the individual projects in a SCCT are project leaders. Indicate where, in the chain of responsibility, advisory groups (internal and external consultants) would be used. Advisory groups: Advisory groups: Provide a description of the function of advisory groups (internal and external) used to provide advice and quality control. Identify the expertise needed but do not identify by name the external consultants who may be recruited to advisory groups. These individuals should not be recruited prior to completion of application review. Specific managerial responsibilities: Indicate who would be responsible for assisting the SCCT Director with the day-to-day administrative details, program coordination, and the planning and evaluation of the program. Relation of the SCCT organization to the administration of the applicant institution: Describe the relation between the proposed SCCT and other existing research, academic, and administrative units of the applicant institution such as schools, centers, institutions, departments, and central administration. Consortium arrangements: If a SCCT application includes research activities that involve institutions other than the sponsoring organization, the program is considered a consortium effort. Such activities may be included in a SCCT grant application, but it is imperative that a consortium application be prepared so that the programmatic, fiscal, and administrative considerations are explained fully. The published policy governing consortia is available in the business offices of institutions that are eligible to receive Federal grants-in-aid. Consult the latest published policy governing consortia before developing the application. If clarification of the policy is needed, contact Ms. Ryan Lombardi at the Grants Operations Branch, Division of Extramural Affairs, NHLBI, at 301-435-0177. Principal Investigators of SCCTs should exercise great diligence in preserving the interactions of the participants and the integration of the consortium projects with those of the parent institution. Designation of replacement for SCCT DIRECTOR: Describe the procedure for appointing a replacement for the SCCT Director, should the need arise. The proposed replacement SCCT Director should meet all of the applicable criteria. The NHLBI must approve the replacement of the SCCT Director should the need arise. Designation of research projects for SCCT: In a Table (see Table 3), please provide a designation as to project type under the following 3 categories: In addition, provide a rationale for the designation. A research project can also include a combination of basic and clinical research, however, each project should be designated as clinical or basic depending on the project's major emphasis. TABLE 3 (Example)
* The specific aims or effort and budget must be predominately clinical research as defined in the SCCT RFA. Individual Projects (for SCCT applications a. Specific Aims List the specific aims of the research project for the total period of requested support. Indicate the general priority of each aim in the overall research plan. b. Background and Significance Review the most relevant previous work and describe the current status of research in this field; document with complete references. Specify the overall biomedical significance of the work proposed and the relevance of the research project to the theme of the SCCT. c. Preliminary Studies Refer to PHS Form 398 Instructions for Preliminary Studies. d. Research Design and Methods Give details of the research plan, including a description of the experiment or other work proposed; present the methods and techniques to be used; note the limitations, if any, of the procedures proposed. Insofar as possible, describe the experiments in the sequence in which they would be conducted. (It is important to convey to the reader that the proposed effort would require the time requested for the project period.) e. Human Subjects The NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study. Special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders, and conditions that disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear and compelling rationale should be provided. A description of the current policy references can be found on the NIH internet site at http://grants.nih.gov/grants/funding/women_min/women_min.htm . The composition of the proposed study population must be described in terms of gender, racial, and ethnic groups. These issues must be addressed in developing a research design sample size appropriate for the scientific objectives of the study. This information must be included in PHS Form 398 (rev. 5/01) in Section 8 of the Research Plan (parts a through d) AND summarized in Section 8, part e, Human Subjects Research. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of U.S. racial and ethnic minority groups. However, the NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of US racial and ethnic minority populations (i.e., American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander). The Office of Management and Budget Directive No. 15 describes these categories; it can be found at www.whitehouse.gov/omb/fedreg/ombdir15.html. The rationale for studies of single US racial or ethnic minority population groups should be provided. It is the policy of the NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the NIH Policy and Guidelines on the NIH internet site at http://grants.nih.gov/grants/funding/children/children.htm .
Ms. Sheri Hicks f. Vertebrate Animals (see PHS Form 398 Instructions) If animals are involved in a project or core, address all points as specified in the PHS 398 instructions, including the kinds of animals to be used, whether nonhuman primates are to be used, listing the special justifications for their use, and indicate all details for the care, use, treatment, and dispatch of all animals. g. Literature Cited Include a complete citation for each reference in the text. h. Consortium/Contractual Arrangements and/or Collaborative Arrangements (See PHS Form 398 Instructions) Describe the collaboration of investigators within the SCCT. Describe in detail any other collaborative arrangements anticipated, either within the applicant institution or between institutions. I. Consultants (see PHS Form 398 Instructions) Provide a justification for consultants and attach letters from all individuals confirming their roles in the project. k. Facilities Available Describe the facilities to be used by EACH research project. This is to be accomplished as described under "Resources," in PHS Form 398 grant application, page 15. 9. APPENDIXES Appendix material should NOT be included as part of the grant application. Once the application has been received, the Scientific Review Administrator will send the applicant instructions for submitting appendix material. This material includes reprints pertinent to each project or core, and color or half-tone figures. The reviewers will not receive an original copy of the grant application so the appendix should include either originals of the pages or full size copies of any figures where color or clarity is critical to the review. As the PHS Form 398 instructions indicate, the appendix should not be used to circumvent the page limitations. 10. FORMAT OF A CORE UNIT A core unit is defined as a resource for the program project that provides centralized services to two or more of the research projects. a. Title of core unit Title and assign a LETTER designation to each core so that it can be readily distinguished from any other core unit. Do NOT exceed 56 typewriter characters/spaces for its title. b. Names and titles of investigators Provide the name and academic title of the core unit leader and each participating investigator. c. Description of core unit Describe the function of the core unit as a resource to the SCCT. This section must present clearly the facilities, techniques, and professional skills that the core unit would provide. As justification for the core unit, indicate briefly the specific research projects that would use the resources of the core unit. A core unit is principally designed as a service or resource component; it would be highly unusual to include research in a core unit (a possible exception would be methodology development). Please contact the Institute staff if you require guidance on this issue. d. Facilities available Describe the facilities to be used by EACH core unit. This is to be accomplished by completing the "Resources" page included in the PHS Form 398 grant application, page 15. e. Budget for core unit Present the budget for each core unit in the format and according to the instructions indicated for Form 398. A budget for the entire proposed project period is required for all subsequent years of support (direct costs only). Include explicit and detailed budget justifications for all years. f. Relation of core units to research projects To aid in the review of your application it is recommended that you prepare in tabular form information concerning the research projects that each core unit would serve and the proportion of the cost of the core unit associated with each research project involved, according to the format presented in Sample Table 2 in the Illustrations. g. Illustrations in grant application Sample Table 1 is found in all Form 398 applications (Form Page 4) . Preparation of Sample Table 2 is suggested to help the reviewers in the evaluation of a SCCT grant application.
TABLE 2
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